Recon: FDA approves GSK's three-drug asthma inhaler; EMA extends review of BioMarin gene therapy

• Senior FDA career executives: We're following the science to protect public health in pandemic (USA Today)
• The coronavirus pandemic underscores the need to bring drug manufacturing back to US (CNBC)
• Several Covid-19 Vaccines Could Join Winner’s Circle (WSJ)
• GSK's three-drug inhaler wins US nod for use in asthma patients (Reuters) (Endpoints)
• Trump said he knew virus was deadly but still played down crisis: Woodward book (Reuters)
• Senate polarized over next coronavirus aid package (Reuters)
• Most Adults Wary of Taking Any Vaccine Approved Before the Election (KHN)

• AstraZeneca expects COVID vaccine result by year-end if trials resume (Reuters)
• Serum Institute pauses India trials of AstraZeneca's COVID-19 vaccine (Reuters)
• World must scale up clinical trials to address COVID-19, WHO says (Reuters)
• UN's Guterres calls for $35 billion more for WHO COVID-19 program (Reuters)
• EU review extended for BioMarin's gene therapy Valrox (PharmaTimes)
• AstraZeneca's asthma drug succeeds late-stage study (Reuters)
• China’s Baidu is in talks to raise up to $2 billion to launch a stand-alone biotech company (CNBC)
• Germany Sets Direction Of Travel With New Biosimilar Guidelines (Pink Sheet)

• ‘You can’t rush science’ — Merck CEO stresses need for careful approach to coronavirus vaccine (CNBC)
• Scientists question ‘strange’ data in Russian coronavirus vaccine trial after ‘unlikely’ patterns (CNBC)
• 8,000 jumbo jets needed to deliver coronavirus vaccines globally, IATA warns (CNBC)
• Why the FDA authorized just one test to classify all Covid-19 plasma (Quartz)
• ‘Hell has frozen over’: The pharmaceutical industry stands in for a politically impaired FDA (STAT)
• The Pony Express? US Postal Service changes continue to slow down deliveries of mail-order prescriptions (STAT) (The Hill)
• Exclusive: Ginkgo teams with unknown upstart in hunt for Covid-19 antibody (Endpoints)
• Top FDA Officials Explain Standards For Take-Home COVID-19 Tests (MedtechInsight)
• Key FDA Drug Inspection Challenges Amid COVID-19 (Law360)

• FDA Delays Start of Sarepta’s Gene Therapy Trial. That Doesn’t Faze the Stock’s Bulls. (Barron's) (Endpoints)
• Casma Therapeutics brings in another $50 million to target muscular dystrophy (STAT)
• Korro Bio raises $90 million to fix mutations that cause diseases (STAT)
• The Risks of the Prescribing Cascade (NYTimes)
• Takeda reports PhIII failure for Ninlaro in multiple myeloma; AstraZeneca plots pivot to Nasdaq (Endpoints)
• Upcoming market catalysts in Q4 2020 (Nature)
• 23andMe’s next challenge: ensuring its customers can get drugs developed with their data (STAT)
• MilliporeSigma Plans $65 Million Manufacturing Expansion (GEN)
• Animal data in hand, Nessan Bermingham banks $91.5M for Atlas-backed RNA editing play (Endpoints)
• Intra-Cellular's Caplyta could cruise toward blockbusterland with bipolar depression win: analyst (Fierce)
• FL56+FL57= infinite possibilities? Flagship's hybrid startup takes machine learning in drug discovery to the next level — and Covid-19 offers a quick test (Endpoints)
• Orasis Pharmaceuticals snags $30M to see its presbyopia treatment through to PhIII (Endpoints)
• MiNA Therapeutics bags nearly $30M Series A to push activating mRNA tech through the clinic (Endpoints)
• Recursion nabs $239M and an up to $1B partnership with Bayer as AI race heats up (Endpoints)
• Codiak files for an IPO, again, this time shooting for a nine-digit raise (Endpoints)
• Phase III migraine flop sends a small-cap biotech player into a deadly tailspin (Endpoints)
• New data show Roche’s ENSPRYNG (satralizumab) significantly reduces severity and risk of relapse in neuromyelitis optica spectrum disorder (NMOSD) (Press)

• FDA aims to harmonize adverse event reporting with eMDR updates, makes patient problem codes public (MedtechDive)
• Medtronic tricuspid valve replacement device wins FDA breakthrough status (MedtechDive)
• The best TAVR device? Experts opine on when to use Boston Scientific, Edwards or Medtronic valve (MedtechDive)
• Ultrasound ablation provided 'adequate' short-term control for prostate cancer patients, small study shows (MedtechDive)

• Rare Pediatric Disease Voucher Program Gains Temporary Extension From House Committee (Pink Sheet)
• Mallinckrodt Pays Executives $5 Million in Bonuses Ahead of Possible Bankruptcy (WSJ)
• GAO: FDA Could Better Communicate with Airlines to Encourage Voluntary Construction Inspections of Aircraft Galleys and Lavatories (GAO)
• Hospitals urge HHS to step in on 340B fight with drugmakers (BioPharmaDive)
• Drugmakers Want Zetia 'Shortcut' Cert. Short-Circuited (Law360)
• Doctor Says FDA Made Wrong Call On Opioids In NY AG Suit (Law360)
• House Committee Advances Medical Marijuana Research Bill (Law360)
• AAM Renews Challenge to California’s Law Targeting Pharmaceutical Patent Infringement Settlements (Big Molecule Watch)
• Snyders Heart Valve LLC v. St. Jude Medical, LLC (Fed. Cir. 2020) (Patent Docs)